SSIPP vs. PST vs. WLC

NCT04887350 | Withdrawn Phase 1

• 1 other identifier: 11336
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 pandemic and continued lockdown measures have led to social isolation that is likely disproportionately affecting community-dwelling seniors. This social isolation of seniors is expected to cause detrimental health effects especially in those who have an ongoing or new onset late life depressive episode. The COVID-19 pandemic has also made accessing formal psychotherapy services increasingly difficult due to an increased demand for these services and a limited number of trained professionals available to deliver these interventions. We plan to conduct an open label, pilot, randomized controlled trial (RCT), comparing a virtually delivered (telephone) student led mental health supportive initiative, Student Senior Isolation Prevention Partnership (SSIPP) (n=15) compared to a telephone delivered standard psychotherapy intervention, problem-solving therapy (PST) (n=15) versus a wait list control (n=15) in community-dwelling seniors suffering from late life depression. Participants in this study will be blinded to the hypothesis, while those performing data analysis will be blinded to treatment allocation. Both SSIPP and PST will be delivered via telephone as a weekly session for 12-weeks. Feasibility measures of recruitment, retention and costs will be collected as primary outcome measures. Self-rated measures of depression, anxiety, isolation and resilience will comprise secondary exploratory outcomes. We anticipate that it will be feasible to conduct an RCT of these telephone interventions, SSIPP and PST, in socially isolated community-dwelling seniors. Data from this study will be critical to plan a subsequent confirmatory large-scale RCT. It could be that telephone delivered medical student led supportive intervention, SSIPP and/or a telephone delivered psychotherapy initiative, PST, can be feasibly applied in the current pandemic to a high-risk population, isolated seniors suffering from depression.

Conditions

Major Depressive Disorder; Late Life Depression

Outcome Measures

Primary Outcomes (5)

• Rate of participant recruitment

  The number of participants recruited per month will be calculated by dividing the total number of participants at the end of the study by the number of study months over which recruitment took place.

  through study completion, an average of 1 year

• Rate of retention

  The retention rate will be calculated by dividing the total number of participants who completed a week 12 study assessment by the total number of participants enrolled in the study.

  through study completion, an average of 1 year

• Completeness of data entry

  Completeness of data entry will be calculated by dividing the number of completed CRF's at the end of the study by the CRF maximum potential completion number.

  through study completion, an average of 1 year

• Cost of interventions

  The cost of study intervention will be calculated by dividing the total number of participants who attended at least one study intervention by the total cost of interventions to determine a cost per participant.

  through study completion, an average of 1 year

• Unexpected costs

  Any unanticipated costs will be recorded and reported at the end of the study.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Depression

  Week 0, Week 12

• Anxiety

  Week 0, Week 12

• Resilience

  Week 0, Week 12

• Isolation

  Week 0, Week 12

Study Arms (3)

Student-Senior Isolation Prevention Partnership (SSIPP)

EXPERIMENTAL

The Student-Senior Isolation Prevention Partnership is a phone administered talk therapy.

Behavioral: Student-Senior Isolation Prevention Partnership (SSIPP)

Problem Solving Therapy (PST)

ACTIVE COMPARATOR

Problem Solving Therapy is a phone administered talk therapy.

Behavioral: Problem Solving Therapy (PST).

Wait List Control (WLC)

OTHER

Participants in the WLC will continue with their regular treatments for the 12 week study period but not receive any study related intervention during this 12 weeks. Following completion of all study assessments WLC participants will self-select either SSIPP or PST. Participants in WLC will not complete study assessments after week 12.

Behavioral: Student-Senior Isolation Prevention Partnership (SSIPP); Behavioral: Problem Solving Therapy (PST).

Interventions

Student-Senior Isolation Prevention Partnership (SSIPP) BEHAVIORAL

The Student-Senior Isolation Prevention Partnership partners medical students with older adults in the community to provide social support and connection through regular phone calls. The goal of SSIPP is to reduce rates of anxiety, depression, and loneliness, while fostering resilience among seniors in our communities. This intervention will be delivered by phone to study participants once a week for a 30-60 minute session over a 12-week period.

Student-Senior Isolation Prevention Partnership (SSIPP); Wait List Control (WLC)

Problem Solving Therapy (PST). BEHAVIORAL

Problem Solving Therapy is a psychotherapeutic intervention that teaches community members to identify and clarify problems at hand, set clear, achievable goals, brain-storm solutions to the problem, select their preferred solution, implement this solution, and evaluate the outcomes. This intervention will be delivered by a trained healthcare professional by phone to study participants once a week for a 30-60 minute session over a 12-week period.

Problem Solving Therapy (PST); Wait List Control (WLC)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Community-dwelling senior 65 years of age or older.
• Meeting criteria of suffering from an episode of major depression, mild to moderate, as assessed by an experienced psychiatrist (DSM 296.21, 296.22, 296.31, 296.32), with the following applicable specifiers including anxious distress, mixed features, melancholic features, atypical features and seasonal pattern
• Willing to receive services via telephone.
• Have sufficient hearing to converse via telephone.
• Have an adequate understanding of written and spoken English.
• Answer yes to the question "do you perceive that you are either lonely or isolated?"

You may not qualify if:

• Pre-existing dementia or other neurodegenerative disorder as confirmed by a Montreal Cognitive Assessment (MoCA) score, telephone version, 17 or below
• History of schizophrenia
• History of bipolar disorder
• History of substance use disorder
• History of personality disorder as per previous clinical documentation
• History of suicide attempts or threats as per previous clinical documentation or endorsement of any of the questions from item 2-6 of the Columbia- Suicide Severity Rating Scale.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Related Publications (3)

• Banerjee D. The impact of Covid-19 pandemic on elderly mental health. Int J Geriatr Psychiatry. 2020 Dec;35(12):1466-1467. doi: 10.1002/gps.5320. Epub 2020 Jun 27. No abstract available.

  PMID: 32364283 BACKGROUND

• Wang L, He W, Yu X, Hu D, Bao M, Liu H, Zhou J, Jiang H. Coronavirus disease 2019 in elderly patients: Characteristics and prognostic factors based on 4-week follow-up. J Infect. 2020 Jun;80(6):639-645. doi: 10.1016/j.jinf.2020.03.019. Epub 2020 Mar 30.

  PMID: 32240670 BACKGROUND

• Armitage R, Nellums LB. COVID-19 and the consequences of isolating the elderly. Lancet Public Health. 2020 May;5(5):e256. doi: 10.1016/S2468-2667(20)30061-X. Epub 2020 Mar 20. No abstract available.

  PMID: 32199471 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Akshya Vasudev, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All study participants will be blinded to the study hypotheses to prevent expectation bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in a 1:1:1 ratio to one of the three study groups.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 14, 2021
• Study Start: August 9, 2021
• Primary Completion: April 9, 2022
• Study Completion: April 9, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

CA (1)